JP2005518907A - Medical connector assembly for fluid transfer - Google Patents

Medical connector assembly for fluid transfer Download PDF

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JP2005518907A
JP2005518907A JP2003574266A JP2003574266A JP2005518907A JP 2005518907 A JP2005518907 A JP 2005518907A JP 2003574266 A JP2003574266 A JP 2003574266A JP 2003574266 A JP2003574266 A JP 2003574266A JP 2005518907 A JP2005518907 A JP 2005518907A
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coupling
holding means
coupling assembly
reservoir
delivery device
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JP4871492B2 (en
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ピエール、ロワ
アラン、クレンシンゲール
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Optis SA
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Optis SA
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/221Frangible or pierceable closures within tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/1011Locking means for securing connection; Additional tamper safeties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/348Constructions for connecting the needle, e.g. to syringe nozzle or needle hub snap lock, i.e. upon axial displacement of needle assembly
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16LPIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
    • F16L37/00Couplings of the quick-acting type
    • F16L37/08Couplings of the quick-acting type in which the connection between abutting or axially overlapping ends is maintained by locking members
    • F16L37/084Couplings of the quick-acting type in which the connection between abutting or axially overlapping ends is maintained by locking members combined with automatic locking
    • F16L37/098Couplings of the quick-acting type in which the connection between abutting or axially overlapping ends is maintained by locking members combined with automatic locking by means of flexible hooks
    • F16L37/0985Couplings of the quick-acting type in which the connection between abutting or axially overlapping ends is maintained by locking members combined with automatic locking by means of flexible hooks the flexible hook extending radially inwardly from an outer part and engaging a bead, recess or the like on an inner part
    • F16L37/0987Couplings of the quick-acting type in which the connection between abutting or axially overlapping ends is maintained by locking members combined with automatic locking by means of flexible hooks the flexible hook extending radially inwardly from an outer part and engaging a bead, recess or the like on an inner part the flexible hook being progressively compressed by axial tensile loads acting on the coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1475Inlet or outlet ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/10Coring prevention means, e.g. for plug or septum piecing members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1027Quick-acting type connectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M2039/1061Break-apart tubing connectors or couplings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/27General characteristics of the apparatus preventing use
    • A61M2205/273General characteristics of the apparatus preventing use preventing reuse, e.g. of disposables

Abstract

The invention relates to a connector assembly (10) for the transfer of fluids, particularly fluids comprising an active agent from a reservoir to a medical device for dosage, comprising: a first connector element (20), pertaining to the reservoir with first fixing means (23), a second connector element (10), pertaining to the medical dosage device with second fixing means (12), cooperating with the first fixing means to give an irreversible connection between the two elements. The first and second elements are embodied such as to cooperate with other by clipping on a single translational movement of a connector element relative to the other to produce the irreversible connection, characterized in that at least one of the connection elements is embodied with means to render the same breakable.

Description

本発明は、流体、詳細には医薬品を、リザーバから医療用送出装置に移送するように構成された医療用連結システムに関する。   The present invention relates to a medical coupling system configured to transfer fluid, in particular pharmaceutical products, from a reservoir to a medical delivery device.

本明細書において、「流体」という用語は、感染症又は受傷のケア又は治療を行うように、又は生体機能を修正し又は変更するように、又は診断を行うように設計された、化学合成又は天然抽出化合物によって得られた、様々な医薬品又は有効製品に関連するものである。例えば、抗炎症薬、抗生物質、抗菌剤、防かび剤、抗ガン剤、抗脈管形成剤、抗緑内障剤、神経保護剤、神経変調剤、アナエセティックス(anaesthetics)、オリゴヌクレオチド等の遺伝子治療用製品、プラスミド、栄養剤、ビタミン、塩、ミネラル、及びホルモン剤が挙げられる。流体には、血液等の体液、その成分の一つである、胃液や尿等が含まれる。   As used herein, the term “fluid” refers to chemical synthesis or to be designed to provide care or treatment for an infection or injury, or to modify or alter a biological function, or to make a diagnosis. It relates to various pharmaceuticals or active products obtained by natural extract compounds. For example, anti-inflammatory agents, antibiotics, antibacterial agents, antifungal agents, anticancer agents, antiangiogenic agents, antiglaucoma agents, neuroprotective agents, neuromodulators, anaesthetics, oligonucleotides, etc. Examples include gene therapy products, plasmids, nutrients, vitamins, salts, minerals, and hormonal agents. The fluid includes bodily fluids such as blood and gastric juice and urine which are one of its components.

医薬品の定義についての別の情報として、医薬品に関する法的要件を取り扱う、1965年1月26日付けの欧州指令(European Directive)65/65/CEEには、以下の通り定義されている。   Additional information on the definition of pharmaceuticals is defined in the European Directive 65/65 / CEE dated January 26, 1965, which deals with legal requirements regarding pharmaceuticals as follows:

『以下の定義は、本指令の用途に適用することができる。
1.薬品の特質
薬品は、予め調製され、特別の名称で特別のパッケージに入れて販売される。
2.医薬品
人間や動物の疾病を緩和したり予防したりする性質を持つ任意の物質又は配合物。
医療的診断を行ったり、人間や動物の生体機能を復元し、正し又は変更するために人間や動物に投与される任意の物質又は配合物。
3.物質
由来に係わらない任意の材料。
由来には、
−人間の血液及び人間の血液から得られた製品、
−動物性微生物、全ての動物、組織片、動物の分泌物、毒素、抽出によって得られた物質、血液から得られた製品等、
−植物性微生物、植物、植物片、植物の分泌物、抽出によって得られた物質等、
−元素等の化学物質、天然の化学物質、及び化学転移及び合成製品がある。
4.特別処方
特定の患者用の処方を使用して薬局で調製した任意の薬剤。
5.薬局方処方
薬局方の指示に従って薬局で調製した任意の薬剤。これは患者に直接出され、この薬局を通して供給される。』
“The following definitions are applicable to the use of this directive.
1. Characteristics of medicines Medicines are prepared in advance and sold in special packages with special names.
2. Drug Any substance or compound that has the property of alleviating or preventing human and animal diseases.
Any substance or formulation that is administered to a human or animal in order to make a medical diagnosis or to restore, correct or change the biological function of a human or animal.
3. Substance Any material not related to origin.
The origin is
-Human blood and products obtained from human blood,
-Animal microorganisms, all animals, tissue fragments, animal secretions, toxins, substances obtained by extraction, products obtained from blood, etc.
-Plant microorganisms, plants, plant fragments, plant secretions, substances obtained by extraction, etc.
-There are chemicals such as elements, natural chemicals, and chemical transfer and synthetic products.
4). Special prescription Any drug prepared at a pharmacy using a prescription for a specific patient.
5. Pharmacopoeia prescription Any drug prepared at the pharmacy according to the instructions of the pharmacopoeia. This is delivered directly to the patient and supplied through this pharmacy. 』

これは、1993年7月22日付けの指令によって補完される。   This is supplemented by a directive dated July 22, 1993.

『以下のバイオテクノロジープロセスの一つから得られる薬剤。
−デオキシリボ核酸技術の組み替え、
−変換された哺乳動物の細胞を含む、原核生物及び真核生物の生物学的に有効な蛋白質についての遺伝子コードの表現の制御、
−雑種及び単クローン抗体に基づく方法。
バイオテクノロジーで得られたのでない薬剤を含む、成長を促進するため、又は治療した動物の生産性を高めるための主に性能を高めるための薬剤として使用されるようになった獣医学的薬剤』
“Drugs from one of the following biotechnology processes.
-Recombination of deoxyribonucleic acid technology,
Control of the expression of the genetic code for prokaryotic and eukaryotic biologically effective proteins, including transformed mammalian cells,
-Methods based on hybrid and monoclonal antibodies.
Veterinary drugs that have come to be used primarily to enhance performance, to promote growth, or to increase the productivity of treated animals, including drugs not obtained through biotechnology

様々な患者間の、又は患者と介護者との間の交差汚染の危険が考慮されてきたため、現在、衛生的な製品として販売され、一回使用した後で廃棄される、「使い捨て」器具の開発によって保証されたように、医療用送出装置を特定の患者に対して一度だけしか使用しないのが習慣であり、場合によっては義務である。同様に、医薬品は、一回分の投与量が入ったバイアルで販売されることが益々多くなってきている。これにより、医薬品を数人の患者に使用することが不可能になり、投与量を誤る危険を制限する。しかしながら、医療用送出装置に「使い捨て」の表示があるにも拘わらず、これらが実際に数人の患者に対して再使用されないようにする方策はとられていない。かくして、例えば、静脈内注入用針を医薬品の一回分の投与量が入った注射器に連結することができ、従って、前記投与量を数人の患者に投与するのに使用することができる。第1に、これらの皮下針及び注射器の再使用の問題に対し、第2に、注射によって誤って汚染が起こることに対し、多くの解決策が提案されてきた。そして常に、注射器及び/又は針の一回使用に帰結した。   Because of the risk of cross-contamination between various patients or between patients and caregivers, it is currently being marketed as a sanitary product that is discarded after a single use. As warranted by development, it is customary and sometimes mandatory to use a medical delivery device only once for a particular patient. Similarly, pharmaceuticals are increasingly being sold in vials containing single doses. This makes it impossible to use the drug for several patients and limits the risk of incorrect doses. However, despite the fact that the medical delivery device has a “disposable” indication, no measures have been taken to ensure that these are not actually reused for several patients. Thus, for example, an intravenous infusion needle can be connected to a syringe containing a single dose of a medicament and thus can be used to administer the dose to several patients. First, many solutions have been proposed to address the problem of reuse of these hypodermic needles and syringes, and second, to accidental contamination caused by injection. And always resulted in a single use of the syringe and / or needle.

しかしながら、幾つかの薬剤は、希釈によって調製する必要がある、例えば凍結乾燥粉体の形態である。このような医薬品の調製は、希釈されるべき形態を溶媒と特定の割合で混合し、得られた溶液を医療用送出装置に移送する。一般的には、先ず最初に溶媒を注射器に吸い込み、次いで、凍結乾燥粉体が入った容器に注入する。混合した後、混合物を再び注射器で吸い上げる。次いで、前記混合物を投与することができるように注射器を医療用送出装置に連結する。従って、混合物を形成するために注射器と様々な容器との間を必要に応じて何回も連結したり外したりしなければならない。行われる最後の連結は、注射器と医療用送出装置との間の連結である。   However, some drugs need to be prepared by dilution, for example in the form of lyophilized powder. In the preparation of such a pharmaceutical, the form to be diluted is mixed with a solvent in a specific ratio, and the obtained solution is transferred to a medical delivery device. In general, the solvent is first drawn into a syringe and then poured into a container containing the lyophilized powder. After mixing, the mixture is again sucked up with a syringe. The syringe is then connected to a medical delivery device so that the mixture can be administered. Therefore, the syringe and various containers must be connected and disconnected as many times as necessary to form a mixture. The final connection that is made is the connection between the syringe and the medical delivery device.

米国特許第6,231,552号には、リザーバ(この場合には注射器)と医療用送出装置(この場合には皮下針)との間の連結アッセンブリが記載されている。この連結アッセンブリは、標準的な雄ルエルコーンを使用する。内面にねじ山が設けられたコーンのところが同軸の円筒体によって取り囲まれており、ねじ山の自由端にノッチが形成してある。針は、注射器に設けられた雄ルエルコーンと適合する、注射器に設けられたねじ山と相補的なねじ山が皮下針のベースの外面に形成された、標準的な雌ルエルコーンを有する。更に、針に設けられたねじ山の先端でピンが前記外面から突出している。かくして、注射器を針に連結するとき、上述した二つのねじ山を螺着によって協働させた後、皮下針に設けられたピンが、このピンのために注射器に設けられたノッチに不可逆的にクリップ止めされる。これによって得られたシステムにより、リザーバ及び医療用送出装置が外れないようにすると同時に、標準的な雄及び雌の「係止」型ルエルコネクタを(以上に説明したのと同様のねじ山で)不可逆的に連結することができる。このシステムは、突出ピン又はこのピンが嵌着するノッチのいずれかが設けられたルエルコーン間を連結した場合にのみ不可逆的になる。   US Pat. No. 6,231,552 describes a coupling assembly between a reservoir (in this case a syringe) and a medical delivery device (in this case a hypodermic needle). This coupling assembly uses a standard male luer cone. A cone with a thread on the inner surface is surrounded by a coaxial cylinder, and a notch is formed at the free end of the thread. The needle has a standard female luer cone with a thread formed on the outer surface of the hypodermic needle base that is complementary to the thread provided on the syringe that is compatible with the male luer cone provided on the syringe. Furthermore, a pin projects from the outer surface at the tip of a thread provided on the needle. Thus, when the syringe is connected to the needle, after the two threads described above have been brought together by screwing, the pin provided on the hypodermic needle is irreversibly in the notch provided on the syringe for this pin. Clipped. The resulting system prevents the reservoir and medical delivery device from disconnecting, while at the same time standard male and female “locked” luer connectors (with similar threads as described above). It can be irreversibly linked. This system is irreversible only when connecting between luer cones provided with either a protruding pin or a notch into which the pin fits.

この種の装置の欠点は、このようなシステムを不可逆的に連結するために、及び連結部を形成するために、使用者が並進移動を回転移動(螺旋的移動)と組み合わせて行わなければならないということである。この際、二つの要素間で前記の不可逆的保持手段を係合させるため、ねじ込みの終了時に追加の力を加える。この際、連結部を液密にするように雄及び雌のルエルコーンは接触によって既に協働している。   The disadvantage of this type of device is that the user must perform a translational movement combined with a rotational movement (spiral movement) in order to irreversibly connect such a system and to form a connection. That's what it means. At this time, in order to engage the irreversible holding means between the two elements, an additional force is applied at the end of the screwing. At this time, the male and female luer cones are already cooperating by contact so as to make the connecting part liquid-tight.

本発明の一つの目的は、一回の連結移動中に組み立てられるリザーバと医療用送出装置との間に不可逆的連結アッセンブリを提供することである。   One object of the present invention is to provide an irreversible coupling assembly between a reservoir assembled during a single coupling movement and a medical delivery device.

この目的を達成するため、本発明によれば、流体、詳細には有効製品を含む流体を、リザーバから医療用送出装置に移送するための連結アッセンブリであって、リザーバと関連した、第1保持手段を含む第1連結要素と、医療用送出装置と関連した第2連結要素であって、第1保持手段と協働して二つの連結要素間に不可逆的連結部を形成する第2保持手段を含む第2連結要素とを備え、前記第1保持手段及び前記第2保持手段は、一方の連結要素を他方に関して並進移動させて不可逆的連結部を形成するときにクリッピングによって互いに協働するように構成されている、連結アッセンブリが提供される。   To this end, according to the present invention, a coupling assembly for transferring a fluid, in particular a fluid containing an active product, from a reservoir to a medical delivery device, the first holding associated with the reservoir. A first connecting element including means and a second connecting element associated with the medical delivery device, wherein the second holding means cooperates with the first holding means to form an irreversible connecting portion between the two connecting elements. The first holding means and the second holding means cooperate with each other by clipping when the one connecting element is translated with respect to the other to form an irreversible connecting portion. A coupling assembly is provided.

かくして、保持手段のこの特定の構成により、使用者は医療用送出装置をリザーバに連結することができる。医療用送出装置及びリザーバは、両方とも、雄及び雌のルエルコーン等の標準的な連結要素で通常行われるように並進移動を一回行うことによってこれらを互いに不可逆的に連結するためのこのような連結要素が設けられている。   Thus, this particular configuration of retaining means allows the user to connect the medical delivery device to the reservoir. Both the medical delivery device and the reservoir are designed to irreversibly connect them to each other by performing a single translational movement as is normally done with standard connection elements such as male and female luer cones. A connecting element is provided.

有利には、全ての連結要素は、以下に列挙する追加の特徴のうちの少なくとも一つを備えている。即ち、
−第1保持手段又は第2保持手段のいずれか一方が、少なくとも一つの弾性変形可能なタブを含み、他方の保持手段が、タブと協働することができる少なくとも一つのリップを含み、
−第1保持手段又は第2保持手段のいずれか一方が、連結要素の両側に配置された2つのタブを含み、
−第1保持手段又は第2保持手段のいずれか一方が、少なくとも一つの凹所を有し、他方の保持手段が、凹所と協働することができる少なくとも一つのリップを含み、
−リップは弾性変形可能であり、
−第1連結要素又は第2連結要素のいずれか一方が、雄部分を含み、他方の連結要素が、雄部分と相補的形状であり且つ連結部を液密にするように雄部分と協働することができる雌部分を含み、
−雄部分及び雌部分は約6%のテーパを持つルエルコーンであり、
−雄部分は本質的にチューブ状の穿孔子であり、及び
−連結要素の少なくとも一方に、その要素を壊すことができるようにする手段が設けられている。
Advantageously, all connecting elements comprise at least one of the additional features listed below. That is,
Either one of the first holding means or the second holding means comprises at least one elastically deformable tab and the other holding means comprises at least one lip capable of cooperating with the tab;
-Either the first holding means or the second holding means comprises two tabs arranged on both sides of the connecting element;
-Either the first holding means or the second holding means has at least one recess, the other holding means comprising at least one lip capable of cooperating with the recess;
The lip is elastically deformable,
-Either the first coupling element or the second coupling element comprises a male part and the other coupling element is complementary to the male part and cooperates with the male part so as to make the coupling part liquid-tight Including a female part that can
The male and female parts are luer cones with a taper of about 6%;
The male part is essentially a tube-shaped piercer, and at least one of the connecting elements is provided with means allowing it to break.

本発明は、更に、流体、詳細には有効製品を含む流体を、リザーバから医療用送出装置に移送するための、保持手段を含む連結要素を含み、保持手段は、二つの連結要素間での一回の並進移動中にこれらの保持手段が他方の連結要素の保持手段とクリッピングによって協働し、二つの連結要素間に不可逆的連結部を形成するように構成されている。   The present invention further includes a connecting element including a holding means for transferring fluid, in particular a fluid containing the active product, from the reservoir to the medical delivery device, the holding means between the two connecting elements. During one translation, these holding means cooperate with the holding means of the other connecting element by clipping to form an irreversible connection between the two connecting elements.

本発明のその他の特徴及び利点は、一実施の形態及び変形例についての以下の説明を読んだ後、更に明らかになるであろう。   Other features and advantages of the present invention will become more apparent after reading the following description of one embodiment and variations.

以下の定義は、本明細書の残りの部分に適用することができる。   The following definitions can apply to the rest of this document.

〔医療用送出装置〕
治療で有効な製品を全身的に又は局所的に投与するために、又は体液、即ち以上に定義した流体を採取するために、人体の組織(皮膚、粘膜、筋肉等)と接触するように、又は人体の穴(口や鼻の穴、膀胱、生殖器、眼、肺等)の一つに貫入するように、又は循環系(静脈、動脈)に貫入するように設計された装置。例としては、医療用送出装置であると考えられる以下の装置が含まれる。即ち、経皮パッチ、筋間ワクチン接種システム、経皮ワクチン接種システム、静脈内カテーテル、尿道プローブ、胃プローブ、皮下針、医薬品をイオン泳動法によって、電気ポレーションによって、又は他のエネルギ源によって送出するためのシステム、気管支サンプリングカテーテル等である。
[Medical delivery device]
To contact a body tissue (skin, mucous membrane, muscle, etc.) in order to administer a therapeutically effective product systemically or locally or to collect a body fluid, ie a fluid as defined above, Or a device designed to penetrate one of the holes in the human body (mouth, nostril, bladder, genital organs, eyes, lungs, etc.) or into the circulatory system (veins, arteries). Examples include the following devices that are considered to be medical delivery devices. Transdermal patches, intramuscular vaccination systems, transdermal vaccination systems, intravenous catheters, urethral probes, gastric probes, hypodermic needles, pharmaceuticals delivered by iontophoresis, electroporation, or other energy sources A system for doing so, a bronchial sampling catheter and the like.

〔医薬品リザーバ即ち流体リザーバ〕
投与の準備ができた医薬品を収容するリザーバ。一回分の投与量が入った可撓性又は剛性のバイアル、数日間に亘って連続的(例えば可撓性灌流パック)又は非連続的(例えば抗生物質治療)のいずれかの態様で投与されるように設計された、治療薬が入ったバイアル、調製した医薬品が入った注射器、エアロゾルバイアル等であってもよい。この医薬品リザーバには、常に、例えば注射器用標準ルエルコーン等の医療用装置に連結することができる端部品、又は剛性ガラスバイアル用の穿刺可能なゴム性ストッパが設けられている。
[Pharmaceutical reservoir or fluid reservoir]
A reservoir that contains medicinal products ready for administration. A flexible or rigid vial containing a single dose, administered in either continuous (eg flexible perfusion pack) or discontinuous (eg antibiotic treatment) over several days It may be a vial containing a therapeutic agent, a syringe containing a prepared pharmaceutical product, an aerosol vial, etc. The drug reservoir is always provided with an end piece that can be connected to a medical device such as a standard luer cone for syringes, or a puncturable rubber stopper for rigid glass vials.

〔ルエル〕
標準的な雄又は雌の連結要素であり、約6%のテーパを持つ円錐体を含み、入口の直径が約4mm(雄について)又は約4.3mm(雌について)であり、医療用に使用され、ISO国際規格によって定められており、全ての灌流ライン及び輸液ライン(静脈内カテーテル、注射器及び皮下針等)で使用される。
[Ruel]
Standard male or female connecting element, including a cone with a taper of about 6%, inlet diameter of about 4 mm (for male) or about 4.3 mm (for female), used for medical purposes Defined by ISO international standards and used in all perfusion and infusion lines (such as intravenous catheters, syringes and hypodermic needles).

〔スパイク〕
内容物にアクセスするため、医薬品容器(バイアル)のゴム製ストッパ(セプタ)を穿刺するのに使用される金属製又はプラスチック製の中空針。これらのスパイクに対して詳細な標準はなく、バイアルだけに標準がある。
〔spike〕
A metal or plastic hollow needle used to puncture a rubber stopper (scepter) of a pharmaceutical container (vial) to access the contents. There is no detailed standard for these spikes, only the vial.

発明を実施するための形態BEST MODE FOR CARRYING OUT THE INVENTION

本発明の第1の実施の形態を図1a乃至図1cを参照して説明する。連結アッセンブリ1は、第1に不可逆的であり且つ第2に液密である連結部を形成するように互いに協働することができる二つの連結要素10、20を含む。   A first embodiment of the present invention will be described with reference to FIGS. 1a to 1c. The coupling assembly 1 includes two coupling elements 10, 20 that can cooperate with each other to form a coupling that is first irreversible and second liquid-tight.

雌コネクタとも呼ばれる連結要素10は全体に細長い回転体形状をしている。内部ダクト17が一方の側から他方の側まで回転軸線(図示せず)と同軸に貫通している。雌コネクタ10は、三つの機能的部分を含む。第1部分14は、好ましくは、医療用送出装置とのインターフェース領域である。この部分により雌コネクタを医療用送出装置(図示せず)に取り付けることができる。例えば、図1に示す場合では、この領域は本質的にチューブ状であり、針又はチューブを受け入れることができる。これは、好ましくは、接着又は挿入成形によって組み立てられる。このインターフェース領域14全体が医療用送出装置の部分であってもよい。この場合、雌コネクタ10は医療用送出装置の一部を形成し、これと一体化される。   The connecting element 10, also called a female connector, has an elongated rotating body shape as a whole. An internal duct 17 passes through from one side to the other side coaxially with a rotation axis (not shown). The female connector 10 includes three functional parts. The first portion 14 is preferably an interface area with the medical delivery device. This portion allows the female connector to be attached to a medical delivery device (not shown). For example, in the case shown in FIG. 1, this region is essentially tubular and can accept a needle or tube. This is preferably assembled by gluing or insert molding. The entire interface area 14 may be part of the medical delivery device. In this case, the female connector 10 forms part of the medical delivery device and is integrated therewith.

雌コネクタの第2の機能部分は、全体にチューブ状の外形を持ち、内面15を持つ液密領域13である。内面15は、この場合、上述した雌ルエルコーンとほぼ等価であり且つ内部ダクト17の一部を画成する接触部を有する。   The second functional part of the female connector is a liquid-tight region 13 having an overall tubular shape and an inner surface 15. The inner surface 15 in this case has a contact portion that is substantially equivalent to the female luer cone described above and that defines part of the inner duct 17.

雌コネクタの第3部分は、他の連結要素と協働して不可逆的連結部を形成するように設計された領域11である。   The third part of the female connector is a region 11 designed to cooperate with other connecting elements to form an irreversible connection.

雌コネクタ10の領域11は、リングそのこのリングに使用された材料から得られた一連のタブ12を含む。これらのタブ12は、その自由端16が内部ダクト17内にて、雄コネクタ20を雌コネクタ10に挿入する矢印Fで示す方向に沿って延びている。これらのタブ12は弾性変形可能である。   Region 11 of female connector 10 includes a series of tabs 12 derived from the material used for the ring. These tabs 12 have free ends 16 extending in the internal duct 17 along the direction indicated by the arrow F for inserting the male connector 20 into the female connector 10. These tabs 12 are elastically deformable.

連結要素20即ち雄コネクタは全体に細長い回転体形状である。内部ダクト25が一方の側から他方の側まで回転軸線(図示せず)と同軸に貫通している。同様に、雄コネクタ20は、以下の三つの機能的部分を含む。部分21は、好ましくは、医薬品を収容したリザーバとのインターフェース領域である。以上に説明したのと同様に、このインターフェース領域21は、好ましくは、医薬品リザーバの一部を形成する。この場合、インターフェース領域21は、任意の本質的にチューブ状の領域の形態である。好ましくは、このインターフェース領域21全体が医薬品リザーバの一部であってもよい。雄コネクタ20はリザーバの一部を形成し、及び従って、これと一体化される。例えば、以下の説明でわかるように、一回分の投与量が入った可撓性医薬品バイアルにこのような雄コネクタを設けてもよい。   The connecting element 20, i.e. the male connector, has a generally elongated rotor shape. An internal duct 25 penetrates coaxially with a rotation axis (not shown) from one side to the other side. Similarly, the male connector 20 includes the following three functional parts. Portion 21 is preferably the interface area with the reservoir containing the medicinal product. As described above, this interface region 21 preferably forms part of a pharmaceutical reservoir. In this case, the interface region 21 is in the form of any essentially tubular region. Preferably, the entire interface area 21 may be part of the drug reservoir. The male connector 20 forms part of the reservoir and is therefore integrated therewith. For example, as can be seen in the description below, such a male connector may be provided in a flexible pharmaceutical vial containing a single dose.

第2部分23は、不可逆的連結部を形成するように雌コネクタの領域11と協働するように設計されている。部分23は、雄コネクタの外面から突出したリップ23からなる。リップ23は、好ましくは、図1bに示すように雄コネクタ20の全周に亘って連続している。リップ23は、雄コネクタの回転軸線に関して好ましくは約10°乃至45°の所定角度で傾斜した第1面26を有し、第2面27は回転軸線に対してほぼ垂直である。これらの面26、27の交差部がリップ23の頂部を形成する。面26は、矢印Fで示す導入方向に沿っており、面27はその反対側にある。   The second part 23 is designed to cooperate with the region 11 of the female connector so as to form an irreversible connection. The part 23 consists of a lip 23 protruding from the outer surface of the male connector. The lip 23 is preferably continuous over the entire circumference of the male connector 20 as shown in FIG. 1b. The lip 23 has a first surface 26 inclined at a predetermined angle of preferably about 10 ° to 45 ° with respect to the rotation axis of the male connector, and the second surface 27 is substantially perpendicular to the rotation axis. The intersection of these surfaces 26, 27 forms the top of the lip 23. The surface 26 is along the introduction direction indicated by the arrow F, and the surface 27 is on the opposite side.

最後に、雄コネクタを形成する第3部品は、以上に説明した雄ルエルコーンとほぼ等価の外面24を持つ液密領域22である。   Finally, the third part forming the male connector is a liquid-tight region 22 having an outer surface 24 substantially equivalent to the male luer cone described above.

雌コネクタ10は、矢印Fの方向に沿った一回の並進移動を使用して雄コネクタ20と組み立てられる。雄コネクタを雌コネクタに挿入すると、リップ23がタブ12を弾性変形させ、面26がそれらの端部16を押し戻し、次いで、タブ12の端部16は、リップ23の頂部が通過した後にその元の位置に戻り、二つの連結要素が外れないようにする。矢印Fの方向とは逆方向に並進移動させようとすると、タブ12の端部16がリップ23と接触し、特定的には面27と接触して停止し、かくして移動を妨げる。雄コネクタ20を雌コネクタ10に挿入すると、雌ルエルコーン15と雄ルエルコーン24との間の接触により液密領域22が液密領域13と協働し、かくして、それらの相補的形状により、前記連結部を液密にする。かくして、雄コネクタの内部ダクト25を通過する流体は、雌コネクタの内部ダクト17を、医療用送出装置に向かって、連結アッセンブリのところで外側に向かう流体の損失なしに循環させることができる。形成されたアッセンブリを図1cに示す。   Female connector 10 is assembled with male connector 20 using a single translation along the direction of arrow F. When the male connector is inserted into the female connector, the lip 23 elastically deforms the tabs 12, the face 26 pushes back their ends 16, and then the ends 16 of the tab 12 return to their original position after the top of the lip 23 has passed. Return to the position so that the two connecting elements do not come off. When trying to translate in the direction opposite to the direction of arrow F, the end 16 of the tab 12 contacts the lip 23, specifically contacts the surface 27 and stops, thus preventing movement. When the male connector 20 is inserted into the female connector 10, the liquid-tight region 22 cooperates with the liquid-tight region 13 by contact between the female luer cone 15 and the male luer cone 24. Make it liquid-tight. Thus, fluid passing through the internal duct 25 of the male connector can circulate through the internal duct 17 of the female connector toward the medical delivery device without loss of fluid outward at the coupling assembly. The resulting assembly is shown in FIG.

雄コネクタ20の液密領域を形成する部分22は、標準的なルエル型雌コネクタを持つ任意の他の装置に医薬品リザーバを連結する雌ルエルコーンとほぼ等価である。これにより、凍結乾燥製品及び溶媒から溶液を形成することができる。このためには、溶媒が入った装置に連結した後、凍結乾燥製品が入った装置に連結し、医療用送出装置に連結する前に溶液を形成することが必要とされる。   The portion 22 forming the liquid tight region of the male connector 20 is approximately equivalent to a female luer cone that connects the drug reservoir to any other device having a standard luer female connector. Thereby, a solution can be formed from the lyophilized product and the solvent. This requires connecting to a device containing the solvent, then connecting to the device containing the lyophilized product, and forming a solution before connecting to the medical delivery device.

次に、上述した実施の形態の変形例を図2a、図2b及び図2cを参照して説明する。連結アッセンブリ100は、連結要素110即ち雌コネクタと、連結要素120即ち雄コネクタとを含む。以上に説明したのと同様に、コネクタは細長い回転体形状である。コネクタは、回転軸線(図示せず)と同軸の内部ダクト117、125を有する。コネクタは三つの機能的部分を有する。雌コネクタ110は、医薬品送出装置とのインターフェースを形成する機能的部分114を有し、ここでは、端ピースを形成する円錐形ビームの形態で示してある。これは、医薬品送出装置に連結された可撓性チューブに強制的に嵌着される。好ましくは、上述した場合と同様に、インターフェース領域114全体が医療用送出装置の一部を形成し、及びかくして医療用コネクタ110は医療用送出装置の一体の部分を形成する。雌コネクタ110は、液密領域を形成する第2部分113を有する。この部分は本質的にチューブ状の内部接触面115を有し、この内部接触面は、以下に説明するように相補的形状の雄コネクタ120と協働することができる。最後に、雌コネクタ110は、上述した実施の形態の部分11と非常に類似した第3部分111を有する。第3部分は、リング111及び内部ダクト117の各側に設けられた互いに反対側の二つのタブ112を含む。以上に説明したように、タブ112は、コネクタ110のリングと同じ材料で形成されており、矢印Fが示す挿入方向に面しており且つダクト117の内側に面した自由端116を有する。   Next, a modification of the above-described embodiment will be described with reference to FIGS. 2a, 2b, and 2c. The coupling assembly 100 includes a coupling element 110 or female connector and a coupling element 120 or male connector. As described above, the connector has an elongated rotating body shape. The connector has internal ducts 117, 125 that are coaxial with a rotational axis (not shown). The connector has three functional parts. The female connector 110 has a functional portion 114 that forms an interface with the drug delivery device, here shown in the form of a conical beam that forms an end piece. This is forcibly fitted into a flexible tube connected to the drug delivery device. Preferably, as described above, the entire interface region 114 forms part of the medical delivery device, and thus the medical connector 110 forms an integral part of the medical delivery device. The female connector 110 has a second portion 113 that forms a liquid-tight region. This portion has an essentially tubular inner contact surface 115 which can cooperate with a complementary shaped male connector 120 as will be described below. Finally, the female connector 110 has a third part 111 that is very similar to the part 11 of the embodiment described above. The third portion includes two opposite tabs 112 provided on each side of the ring 111 and the internal duct 117. As described above, the tab 112 is formed of the same material as the ring of the connector 110 and has the free end 116 facing the insertion direction indicated by the arrow F and facing the inside of the duct 117.

雄コネクタ120には、流体を医薬品リザーバ(図示せず)から反対端126まで移送するのに使用される内部ダクト125が設けられている。この雄コネクタ120は、三つの機能的部分を有する。部分121は、医薬品リザーバとのインターフェースを形成するように設計されている。このインターフェースは、上述した実施の形態と正確に同じ方法で形成される。このインターフェースは、雌ルエル型コーン127を含んでもよい。雌ルエル型コーンは、相補的雄ルエルコーンを持つリザーバを形成する標準的な注射器と協働するように設計されている。この場合、雄コネクタ120は、連結部を液密にするように雌コネクタ110の表面115と協働することができる本質的にチューブ状の外面124を持つ液密領域122を形成する部分を有する。最後に、雄コネクタ120は、外方に突出したリップ123を含む協働領域123を有する。この領域は、雌コネクタ110のタブ112と協働し、連結を不可逆的にするように設計されている。図2cに示す実施の形態は、図1cに示してあり且つ以上に説明した実施の形態のアッセンブリと同じ方法で製造され且つ組み立てられる。   The male connector 120 is provided with an internal duct 125 that is used to transfer fluid from a drug reservoir (not shown) to the opposite end 126. The male connector 120 has three functional parts. Portion 121 is designed to form an interface with a pharmaceutical reservoir. This interface is formed in exactly the same way as the embodiment described above. This interface may include a female luer cone 127. The female luer cone is designed to work with a standard syringe that forms a reservoir with a complementary male luer cone. In this case, the male connector 120 has a portion that forms a liquid tight region 122 with an essentially tubular outer surface 124 that can cooperate with the surface 115 of the female connector 110 to make the connection liquid tight. . Finally, the male connector 120 has a cooperating region 123 that includes an outwardly projecting lip 123. This region is designed to cooperate with the tab 112 of the female connector 110 to make the connection irreversible. The embodiment shown in FIG. 2c is manufactured and assembled in the same way as the assembly of the embodiment shown in FIG. 1c and described above.

図2a、図2b及び図2cを着目すると、雄コネクタ120の領域122は、有利には、医薬品バイアルのゴム製ストッパを穿刺できるスパイクの形態をなしている。例えば、ストッパを備えたバイアルに入った無菌水又は任意の他の注射用溶媒を採取するため、この種のコネクタを設置することができ又は注射器の一体の部分を形成することができると考えることができる。この無菌水は、次いで、凍結乾燥した有効製品を希釈して溶液を得るため、凍結乾燥した有効製品が入ったストッパを備えた第2バイアルに移送することができ、その後、以上に説明した雌コネクタ110を持つ医療用送出装置に不可逆的に永久的に連結する。   Turning to FIGS. 2a, 2b and 2c, the region 122 of the male connector 120 is advantageously in the form of a spike that can pierce the rubber stopper of the pharmaceutical vial. Consider, for example, that this type of connector can be installed or can form an integral part of a syringe to collect sterile water or any other injectable solvent in a vial with a stopper Can do. This sterile water can then be transferred to a second vial with a stopper containing the lyophilized active product to dilute the lyophilized active product to obtain a solution, after which the female described above Irreversibly and permanently connected to a medical delivery device having a connector 110.

タブ12又は112の最小の数は1個である。しかしながら、雌コネクタのリングの周囲に亘って均等に分配した偶数のタブを設けるのが有利である。一つの変形例を図3に示す。この変形例では、雌コネクタ210は、雌コネクタ110とは、コネクタ210のリングに亘って均等に分配された8個のタブ212を有する点で異なっている。産業的には、図1a乃至図2cに示すように2個のタブを使用するのが好ましい。これは、プラスチックの射出成形による雌コネクタの製造を容易にするためである。   The minimum number of tabs 12 or 112 is one. However, it is advantageous to provide an even number of tabs distributed evenly around the circumference of the female connector ring. One modification is shown in FIG. In this variation, female connector 210 differs from female connector 110 in that it has eight tabs 212 evenly distributed across the ring of connector 210. Industrially, it is preferable to use two tabs as shown in FIGS. 1a to 2c. This is to facilitate the production of a female connector by plastic injection molding.

雌コネクタの第2の変形例を図4に示す。これは、リング312の形態の連続した凹所を形成することを含む。この場合、連結アッセンブリ300は、以上に説明したのと同様の雄コネクタ20と、針314と関連しており且つ以上に説明したコネクタ10と同じ構造を持つ雌コネクタ310とを含む。このコネクタ310は、領域311にタブが設けられておらず、その代わりにリング312の形態の凹所が設けられ、組み立て中にこの凹所に雄コネクタ20のリップ23が嵌まるという点でコネクタ10とは異なる。この種の実施の形態は、コネクタ310が弾性材料で形成されており、そのため、凹所とコネクタ入口との間に配置された円錐部316が、リップ23を凹所に到達するまで通すことができるように、リップ23によって変形できなければならないことを必要とする。   A second modification of the female connector is shown in FIG. This includes forming a continuous recess in the form of a ring 312. In this case, the coupling assembly 300 includes a male connector 20 similar to that described above and a female connector 310 associated with the needle 314 and having the same structure as the connector 10 described above. This connector 310 is not provided with a tab in the region 311, but instead is provided with a recess in the form of a ring 312, so that the lip 23 of the male connector 20 fits into this recess during assembly. Different from 10. In this type of embodiment, the connector 310 is formed of an elastic material so that a conical portion 316 disposed between the recess and the connector inlet can pass the lip 23 until it reaches the recess. It needs to be able to be deformed by the lip 23 so that it can.

次に、雄コネクタ120の変形例を図9及び図10を参照して説明する。雄コネクタ420は、リップ123と医薬品リザーバとのインターフェース領域を形成する部分121との間にコネクタの外周全体に亘って連続したノッチ426が設けられていること以外は雄コネクタ120と同様である。このノッチ426は、小さな剪断力を加えたときにコネクタがこの位置で壊れるように雄コネクタ420をこの場所で弱くする。このいわゆる可壊領域は、医薬品リザーバと医療用送出装置との間で流体を移送した後、この領域を壊してリザーバを装置から離し、雄コネクタの一部を雌コネクタに残すということを意味する。このことは、医薬品を移送した後、医薬品リザーバの部分を医療用送出装置から分離することができ、医薬品送出装置の大きさを使用中に無駄に大きくすることがないようにするということを意味する。更に、雄コネクタの部分が雌コネクタに残ることにより、雌コネクタ及び従って医療用送出装置を後に使用することを更に困難にする。この状況を図10に示す。図10では、雌コネクタ110が医療用送出装置64に、逆止弁65即ち還流防止弁を通して連結されており、これにより、流体が注入後に流出しないようにし、雄コネクタが破裂しないようにする。この場合、雄コネクタ420は、ノッチ426のところで壊して離した状態で示してあり、医薬品リザーバ54を形成する注射器の一体の部分を形成している。   Next, a modification of the male connector 120 will be described with reference to FIGS. The male connector 420 is the same as the male connector 120 except that a continuous notch 426 is provided over the entire outer periphery of the connector between the lip 123 and the portion 121 that forms the interface region between the drug reservoir. This notch 426 weakens the male connector 420 at this location so that when a small shear force is applied, the connector breaks at this location. This so-called breakable area means that after transferring fluid between the drug reservoir and the medical delivery device, this area is broken to separate the reservoir from the device and leave a portion of the male connector on the female connector. . This means that after the drug is transferred, the portion of the drug reservoir can be separated from the medical delivery device, so that the size of the drug delivery device is not increased unnecessarily during use. To do. Furthermore, the portion of the male connector remains in the female connector, making it more difficult to later use the female connector and thus the medical delivery device. This situation is shown in FIG. In FIG. 10, the female connector 110 is connected to the medical delivery device 64 through a check valve 65 or anti-reflux valve, thereby preventing fluid from flowing out after injection and preventing the male connector from rupturing. In this case, the male connector 420 is shown broken apart at the notch 426 and forms an integral part of the syringe forming the drug reservoir 54.

好ましくは、一般的には、連結アッセンブリを形成する、上述した雄コネクタは、医療用リザーバと完全に一体化されており、相補的雌コネクタは医療用送出装置と完全に一体化されているということに着目されたい。   Preferably, the male connector described above, which generally forms the coupling assembly, is fully integrated with the medical reservoir, and the complementary female connector is fully integrated with the medical delivery device. Please pay attention to it.

図5は、図1a乃至図1cに示す連結アッセンブリの第1の使用方法を示す。この場合、雌コネクタ10は、カテーテル又はプローブであってもよい皮下針60に固定された状態で設置される。雄コネクタ10は、更に、医薬品が入った一回投与用又は多数回投与用の注射器に固定的に設置されている。この種の構成では、注射器は標準的な雌ルエルに取り外し自在に連結されてもよいということに着目することが重要である。従って、例えば、標準的な雌ルエルコネクタを備えた源から医薬品又は体液を採取し、医薬品又は流体を採取した後に源から外し、次いで、医療用送出装置60を再度取り外す必要なしにこの流体を針又は上述したカテーテルに注入することができる。   FIG. 5 shows a first use of the coupling assembly shown in FIGS. 1a to 1c. In this case, the female connector 10 is installed in a state of being fixed to a hypodermic needle 60 that may be a catheter or a probe. Further, the male connector 10 is fixedly installed in a single-dose or multi-dose syringe containing a medicine. It is important to note that in this type of configuration, the syringe may be removably connected to a standard female luer. Thus, for example, a drug or bodily fluid is collected from a source with a standard female luer connector, removed from the source after the drug or fluid has been collected, and then this fluid is needled without having to remove the medical delivery device 60 again. Or it can inject into the catheter mentioned above.

図6は、図1a乃至図1cに示す連結アッセンブリの第2の使用方法を示す。この場合、医療用送出装置は、溶質(例えばぶどう糖を含む水)で予め充填された灌流パック61であり、このパック61内の溶質を一回分の投与量の医薬品、例えば抗生物質等と混合するために雌コネクタ10が一体に設けられている。医薬品リザーバを形成し、雄コネクタ20を一体に備えた一回分の投与量が入ったバイアル51を雌コネクタ10に不可逆的に設置する。この種のコネクタを灌流パックへのアクセス経路に置くと、このアクセスを再使用することは不可能になり、このことは、過剰の投与量の医薬品が誤って注入される危険を完全になくす簡単な手段である。   FIG. 6 shows a second use of the coupling assembly shown in FIGS. 1a to 1c. In this case, the medical delivery device is a perfusion pack 61 pre-filled with a solute (for example, water containing glucose), and the solute in the pack 61 is mixed with a single dose of a medicine, such as an antibiotic. Therefore, the female connector 10 is provided integrally. A medicine reservoir is formed, and a vial 51 containing a single dose with a male connector 20 integrated therein is irreversibly installed on the female connector 10. Placing this type of connector in the access path to the perfusion pack makes it impossible to reuse it, which makes it easy to completely eliminate the risk of accidental injection of overdose medication. Means.

図7は、図1a乃至図1cに示す連結アッセンブリの第3の使用方法を示す。この例では、医療用送出装置は、医薬品を眼内に、又は経皮的に、又は経粘膜で移送するための装置であり、雌コネクタ10が装置の一体の部分を形成する。眼内医薬品移送装置は、フランス国特許出願第2 773 320号に更に詳細に記載されている。従って、一回分の投与量が入った可撓性バイアル52にはコネクタ20が装着されている。一回分の投与量が入ったこのバイアルでは、バイアルを医療用送出装置に連結した後、及び医薬品をバイアルから医療用送出装置に移送した後、アッセンブリを二度目に使用することはできない。   FIG. 7 shows a third method of using the coupling assembly shown in FIGS. 1a to 1c. In this example, the medical delivery device is a device for transporting pharmaceuticals into the eye, percutaneously, or transmucosally, and the female connector 10 forms an integral part of the device. An intraocular drug delivery device is described in further detail in French Patent Application No. 2 773 320. Therefore, the connector 20 is attached to the flexible vial 52 containing a single dose. With this vial containing a single dose, the assembly cannot be used a second time after connecting the vial to the medical delivery device and after transferring the drug product from the vial to the medical delivery device.

図8は、図2a、図2b及び図2cに示す本発明の使用方法を示す。   FIG. 8 shows the method of use of the present invention shown in FIGS. 2a, 2b and 2c.

この図は、凍結乾燥形態の医薬品の調製に続いて行われるべき手順を示す。スパイクの形態の雄コネクタ120を注射器又は吸引装置を備えた任意の他の医薬品リザーバに設置し、固定する。第1工程Aでは、溶液が入ったバイアル70の隔膜を穿刺することによって、必要量の溶液を吸い上げる。工程Bでは、予め吸い込んだ溶液を、バイアル71の隔膜を同様の方法で穿刺することによって、凍結乾燥製品が入ったバイアル71に注入する。次いで、溶液をこのバイアルに再び吸い込む。工程Cでは、図面に供給ケーブルによって簡単に示してある医療用送出装置63に連結された雌コネクタ110に注射器53を不可逆的に連結する。   This figure shows the procedure to be performed following the preparation of a lyophilized form of the medicament. A male connector 120 in the form of a spike is placed and secured in a syringe or any other pharmaceutical reservoir equipped with a suction device. In the first step A, a necessary amount of the solution is sucked up by puncturing the diaphragm of the vial 70 containing the solution. In step B, the pre-aspirated solution is injected into the vial 71 containing the lyophilized product by puncturing the septum of the vial 71 in the same manner. The solution is then sucked back into this vial. In step C, the syringe 53 is irreversibly connected to the female connector 110 connected to the medical delivery device 63, which is simply indicated by a supply cable in the drawing.

この種のコネクタを形成するのに使用される材料は、好ましくは、医療用装置用のコネクタの製造でよく使用されるポリマー材料である、この材料は、コネクタのタブの変形によってクリッピングを行うことができる程度の弾性を備えており、良好な機械的強度を提供し、射出成形又は成形金型での成形に適している。例えば、ポリスチレン、ポリカーボネート、ポリ塩化ビニル、ポリエチレン、ポリプロピレン、ポリウレタン、ポリアミド、ポリスルホネート等の材料を使用することができる。材料はこれらに限定されない。更に、この用途で幾つかの合金が適しており、このような合金を選択する上での基準は、可逆的に弾性変形するということである。   The material used to form this type of connector is preferably a polymer material commonly used in the manufacture of connectors for medical devices, this material being clipped by deformation of the connector tabs Therefore, it has good mechanical strength and is suitable for injection molding or molding with a molding die. For example, materials such as polystyrene, polycarbonate, polyvinyl chloride, polyethylene, polypropylene, polyurethane, polyamide, and polysulfonate can be used. The material is not limited to these. In addition, several alloys are suitable for this application, and the criterion for selecting such alloys is that they reversibly elastically deform.

添付図面に示す好ましい実施の形態の雌コネクタは、標準的な雄ルエルコネクタとは使用できないということにも着目されたい。   It should also be noted that the female connector of the preferred embodiment shown in the accompanying drawings cannot be used with a standard male luer connector.

明らかに、本発明の範囲を逸脱することなく、本発明について多くの変更を行うことができる。   Obviously, many modifications can be made to the present invention without departing from the scope of the invention.

例えば、雄コネクタは、リップ23の代わりに、挿入方向に面する変形可能な自由端が外側に設けられた変形可能なタブを備えていてもよい。雌コネクタは、タブ12の代わりに、ダクト17の内側に向かって突出したリップを備えていてもよい。リップは、雄コネクタに設けられたタブと協働して不可逆的連結部を形成し、挿入中にタブを変形させる。タブは、挿入後、最初の位置に戻る。アッセンブリを取り外す逆方向移動は、タブがリップと接触した状態で停止するため、全く不可能である。   For example, the male connector may be provided with a deformable tab having a deformable free end facing the insertion direction on the outside instead of the lip 23. The female connector may include a lip protruding toward the inside of the duct 17 instead of the tab 12. The lip cooperates with a tab provided on the male connector to form an irreversible connection and deforms the tab during insertion. The tab returns to its initial position after insertion. Reverse movement to remove the assembly is completely impossible because the tab stops in contact with the lip.

図1a及び図1bは、本発明の第1の実施の形態の取り外し位置での断面図及び斜視図であり、図1cは、連結位置での断面図である。1a and 1b are a cross-sectional view and a perspective view at a removal position according to the first embodiment of the present invention, and FIG. 1c is a cross-sectional view at a connection position. 図2a及び図2bは、図1の実施の形態の変形例の取り外し位置での断面図及び斜視図であり、図2cは、連結位置での断面図である。2a and 2b are a cross-sectional view and a perspective view at a removal position of a modification of the embodiment of FIG. 1, and FIG. 2c is a cross-sectional view at a connection position. 図1の連結要素の第2の変形例の斜視図である。It is a perspective view of the 2nd modification of the connection element of FIG. 図1の連結アッセンブリの第3の変形例の断面図である。It is sectional drawing of the 3rd modification of the connection assembly of FIG. 図1の発明の第1の使用方法を示す図である。It is a figure which shows the 1st usage method of invention of FIG. 図1の発明の第2の使用方法を示す図である。It is a figure which shows the 2nd usage method of invention of FIG. 図1の発明の第3の使用方法を示す図である。It is a figure which shows the 3rd usage method of invention of FIG. 凍結乾燥させた製品に対する図2の発明の使用方法を示す図である。FIG. 3 shows a method of using the invention of FIG. 2 for a lyophilized product. 本発明の第2の実施の形態の断面図である。It is sectional drawing of the 2nd Embodiment of this invention. 図9の発明の使用方法を示す図である。It is a figure which shows the usage method of invention of FIG.

Claims (12)

流体、詳細には有効製品を含む流体を、リザーバから医療用送出装置に移送するための連結アッセンブリ(10;100;300)であって、
前記リザーバと関連した、第1保持手段(23;123)を含む第1連結要素(20;120)と、
前記医療用送出装置と関連した第2連結要素(10;110;210;310)であって、前記第1保持手段と協働して二つの要素間に不可逆的連結部を形成する第2保持手段(12;112;212;312)を含む第2連結要素とを備え、
前記第1保持手段及び前記第2保持手段は、一方の連結要素を他方に関して並進移動させて不可逆的連結部を形成するときにクリッピングによって互いに協働するように構成されている、連結アッセンブリにおいて、
前記連結要素の少なくとも一方に、その要素を壊すことができるようにする手段が設けられていることを特徴とする連結アッセンブリ。
A coupling assembly (10; 100; 300) for transferring fluid, in particular fluid containing an active product, from a reservoir to a medical delivery device,
A first coupling element (20; 120) comprising first retaining means (23; 123) associated with the reservoir;
A second connecting element (10; 110; 210; 310) associated with the medical delivery device, which cooperates with the first holding means to form an irreversible connection between the two elements. A second coupling element comprising means (12; 112; 212; 312),
In the coupling assembly, the first retaining means and the second retaining means are configured to cooperate with each other by clipping when translating one coupling element relative to the other to form an irreversible coupling,
A coupling assembly, characterized in that at least one of the coupling elements is provided with means allowing the element to be broken.
前記第1保持手段又は前記第2保持手段のいずれか一方が、少なくとも一つの弾性変形可能なタブ(12;112;212)を含み、他方の保持手段が、前記タブと協働することができる少なくとも一つのリップ(23;123)を含むことを特徴とする、請求項1に記載の連結アッセンブリ。   Either the first holding means or the second holding means may include at least one elastically deformable tab (12; 112; 212), and the other holding means may cooperate with the tab. 2. A coupling assembly according to claim 1, characterized in that it comprises at least one lip (23; 123). 前記第1保持手段又は前記第2保持手段のいずれか一方が、前記連結要素の両側に配置された2つのタブを含むことを特徴とする、請求項2に記載の連結アッセンブリ。   The connection assembly according to claim 2, wherein either one of the first holding means or the second holding means includes two tabs arranged on both sides of the connecting element. 前記第1保持手段又は前記第2保持手段のいずれか一方が、少なくとも一つの凹所(312)を有し、他方の保持手段が、前記凹所と協働することができる少なくとも一つのリップを含むことを特徴とする、請求項1に記載の連結アッセンブリ。   Either the first holding means or the second holding means has at least one recess (312), and the other holding means has at least one lip capable of cooperating with the recess. The coupling assembly of claim 1, comprising: 前記リップは弾性変形可能であることを特徴とする、請求項1又は4に記載の連結アッセンブリ。   The connection assembly according to claim 1, wherein the lip is elastically deformable. 前記第1連結要素又は前記第2連結要素のいずれか一方が、雄部分(22;122)を含み、他方の連結要素が、前記雄部分と相補的形状であり且つ連結部を液密にするように前記雄部分と協働することができる雌部分(13;113)を含むことを特徴とする、請求項1乃至5のうちのいずれか一項に記載の連結アッセンブリ。   Either the first connecting element or the second connecting element includes a male part (22; 122), and the other connecting element is complementary to the male part and makes the connecting part liquid-tight. 6. Coupling assembly according to any one of the preceding claims, characterized in that it comprises a female part (13; 113) capable of cooperating with the male part. 前記雄部分及び前記雌部分は約6%のテーパを持つルエルコーン(15、24)であることを特徴とする、請求項6に記載の連結アッセンブリ。   7. A coupling assembly according to claim 6, characterized in that the male part and the female part are luer cones (15, 24) having a taper of about 6%. 前記雄部分は本質的にチューブ状の穿孔子であることを特徴とする、請求項6に記載の連結アッセンブリ。   7. A coupling assembly according to claim 6, characterized in that the male part is essentially a tubular piercer. 注入後に流体が外に出ないようにすることができる逆止手段を更に含み、連結要素を可壊性にすることができる手段を使用することを特徴とする、請求項1乃至8のうちのいずれか一項に記載の連結アッセンブリ。   9. A check means according to claim 1, further comprising a check means capable of preventing the fluid from exiting after injection, the means being able to make the connecting element fragile. A coupling assembly according to any one of the preceding claims. 前記第1連結要素又は前記第2連結要素のいずれか一方を、他方の要素に不可逆的に連結する前に標準的なコネクタに不可逆的に連結することができることを特徴とする、請求項7に記載の連結アッセンブリ。   8. The method of claim 7, wherein one of the first connection element and the second connection element can be irreversibly connected to a standard connector before irreversibly connecting to the other element. A coupling assembly as described. 前記第2連結要素は、前記第1連結要素に不可逆的に連結する前にリザーバに可逆的に連結するため、前記穿孔子を使用することを特徴とする、請求項8に記載の連結アッセンブリ。   9. The coupling assembly according to claim 8, wherein the second coupling element uses the piercer to reversibly couple to a reservoir before irreversibly coupling to the first coupling element. 流体、詳細には有効製品を含む流体を、リザーバから医療用送出装置に移送するための、保持手段を含む連結要素において、前記保持手段は、二つの連結要素間での一回の並進移動中にこれらの保持手段が他方の連結要素の保持手段とクリッピングによって協働し、前記二つの連結要素間に不可逆的連結部を形成するように構成されていることを特徴とする連結要素。   A connecting element comprising holding means for transferring a fluid, in particular a fluid containing an active product, from a reservoir to a medical delivery device, said holding means being in one translational movement between the two connecting elements The connecting element is configured to cooperate with the holding means of the other connecting element by clipping to form an irreversible connecting portion between the two connecting elements.
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